Comparative Effectiveness is defined as the "generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care". It's a hot topic now that goverments worldwide are trying to control rising health care costs.
A recent study was conducted by Goldberg and colleagues at Brigham and Women's Hospital and Harvard University that examined the frequency of comparative effectiveness data being available at the time of market authorization by the FDA for NMEs between 2000 and 2010. The following results were reported:
- 51% (100/197) of approved NMEs had comparative efficacy data at time of authorization
- When orphan drugs (n=37) and drugs without alternatives (n=17) were removed, the percentage rose to 70% (100/143)
- The range varied from only 50% with comparative data in 2008 to 92% in 2010
- NMEs that received priority review were much less likely to have comparative data
Interestingly, and not particularly surprisingly, cancer treatments had comparative data available only 35% of the time. I suspect -- though didn't have data to review -- that cancer also gets higher level of priority review.
The researchers concluded, the "strategies are needed to enhance the accessibility of, and ultimately the use of, this information, particularly in the early marketing experience, when comparative effectiveness data from other sources are scarce or non-existent." See PharmaGossip.
As further segue on this topic, the Pharmalot blog presents an additonal study from the National Pharmaceutical Council. This study polled 111 people from federal agencies, consumer and trade groups, insurers and academics regarding various aspects of comparative effectiveness research (CER). The results:
- 55 percent of respondents were "very familiar" with CER
- 68 percent believe it will take less than 3 years to establish rresearch standards for CER
- 85 percent felt CER had little to no impact on improvement of health care decision making in the past year
- 30 percent believed it would lead to moderate improvements in the next year
- 78 percent believe the Agency for Healthcare Research and Quality (AHRQ) will set standards
- 64 percent the NIH will set standards
- Most believe AHRQ and NIH will set research priorities though 63 percent believe that will fall to the Patient-Centered Outcomes Research Institute (PCORI)
- 85 percent believe academia will do the work and 63 percent believe it will be pharma
There you have it. Bascially, you have a new concept being introduced with the healthcare reform bill. Most believe it will take several years to gain traction. And most believe academia will actually generate the research -- although one might ask where that funding will derive from for head to head clinical studies?
Posted by Bruce Lehr May 4th 2011.
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